Skip to content
Please enter a keyword to search

  • EN ISO 15225:2016

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

    Available format(s): 

    Withdrawn date:  31-10-2016

    Language(s): 

    Published date:  06-04-2016

    Publisher:  Comite Europeen de Normalisation

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principle of structure
    5 Data file dictionary
    Annex A (informative) - Examples for generation of
            generic device group terms and synonyms
    Annex B (informative) - Example of term record
    Annex C (informative) - Examples of collective terms
    Annex D (informative) - Examples of top-level collective
            term nodes
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 15225:2016 specifies rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, healthcare providers and end users.ISO 15225:2016 includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein.The requirements contained in this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification.ISO 15225:2016 does not include the nomenclature itself, which is provided as a separate data file.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/CLC/JTC 3
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Withdrawn

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    06/30123163 DC : 0 BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES
    I.S. CEN/TR 15133:2005 NOMENCLATURE - COLLECTIVE TERMS AND CODES FOR GROUPS OF MEDICAL DEVICES
    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    PD CR 14230:2001 Global medical device nomenclature for the purpose of regulatory data exchange
    UNI CEI EN 980 : 2009 SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    03/314031 DC : DRAFT AUG 2003 BS ISO 7176-26 - WHEELCHAIRS - PART 26: VOCABULARY
    CR 14230 : 2001 GLOBAL MEDICAL DEVICE NOMENCLATURE FOR THE PURPOSE OF REGULATORY DATA EXCHANGE
    CEI UNI EN 1041 : 2014 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    DIN EN 1041:2013-12 Information supplied by the manufacturer of medical devices (includes Amendment A1:2013)
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    UNE-EN 16372:2015 Aesthetic surgery services
    12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    PD CEN/TR 15133:2005 Nomenclature. Collective terms and codes for groups of medical devices
    UNI CEI EN 1041 : 2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    09/30205582 DC : 0 BS EN 15986 - SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    I.S. CR 14230:2001 GLOBAL MEDICAL DEVICE NOMENCLATURE FOR THE PURPOSE OF REGULATORY DATA EXCHANGE
    UNE-EN 1041:2009 Information supplied by the manufacturer of medical devices
    BS EN 1041 : 2008 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    EN 16372:2014 Aesthetic surgery services
    EN 980:2008 Symbols for use in the labelling of medical devices
    I.S. EN 980:2008 SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
    BS EN 16372:2014 Aesthetic surgery services
    06/30122245 DC : 0 EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    BS EN 980:2008 Symbols for use in the labelling of medical devices
    CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
    ISO/IEC 8859-1:1998 Information technology 8-bit single-byte coded graphic character sets Part 1: Latin alphabet No. 1
    ENV 12611 : DRAFT 1997 MEDICAL INFORMATICS - CATEGORICAL STRUCTURE OF SYSTEMS OF CONCEPTS - MEDICAL DEVICES
    ISO 25964-1:2011 Information and documentation — Thesauri and interoperability with other vocabularies — Part 1: Thesauri for information retrieval
    ISO 1942:2009 Dentistry Vocabulary
    ISO 25964-2:2013 Information and documentation — Thesauri and interoperability with other vocabularies — Part 2: Interoperability with other vocabularies
    ISO/IEC 2382:2015 Information technology — Vocabulary
    ISO 10241-1:2011 Terminological entries in standards — Part 1: General requirements and examples of presentation
    ISO 9999:2016 Assistive products for persons with disability Classification and terminology
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective